NCT02672800

Brief Summary

The purpose of this study is to evaluate the feasibility and acceptability of a writing intervention (Reclaiming Yourself), intended to facilitate bereavement for spousal caregivers whose partners died with dementia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

1.8 years

First QC Date

January 28, 2016

Last Update Submit

May 1, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • Inventory of Daily Widowed Life (IDWL)- change at 1 and 2 months post-intervention

    Measure of finding balance in bereavement

    The measure will be administered pre-intervention, 1 month following the introduction of the intervention, and 2 months following the introduction of the intervention

  • Center for Epidemiologic Studies Depression Scale- Revised (CESD-R)- change at 1 and 2 months post-intervention

    Measure of depressive symptoms

    The measure will be administered pre-intervention, 1 month following the introduction of the intervention, and 2 months following the introduction of the intervention

  • Texas Revised Inventory of Grief, Present Feelings- change at 1 and 2 months post-intervention

    Measure of grief

    The measure will be administered pre-intervention, 1 month following the introduction of the intervention, and 2 months following the introduction of the intervention

Secondary Outcomes (1)

  • Semi-structured qualitative evaluation interviews

    Post intervention (after 1 month)

Study Arms (2)

Writing intervention

EXPERIMENTAL
Behavioral: the Reclaiming Yourself tool

Control

NO INTERVENTION

Interventions

This tool is a behavioural writing intervention, intended to facilitate bereavement for spousal caregivers of persons with dementia

Writing intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • bereaved for three months or longer
  • were a caregiver for their spouse with advanced dementia
  • English speaking
  • willing and able to share their bereavement experience

You may not qualify if:

  • those with other than a spousal relationship to the person with dementia
  • spousal caregivers of persons with another terminal disease
  • those bereaved less than 3 months
  • those unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7J3Z1, Canada

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Shelley Peacock, RN, PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, College of Nursing

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 3, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

May 4, 2018

Record last verified: 2018-05

Locations